"Impact of a Closed System in Donor Oocyte Vitrification"
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Locations
- 4
- Primary Endpoint
- Survival after oocyte vitrification using the closed device Cryotop®
Study Overview
Brief Summary
This study is aimed to evaluate the use of a closed device for storage of vitrified oocytes.
Detailed Description
The Cryotop method for oocyte vitrification is classified as "open system", which means that it requires direct contact with liquid nitrogen during the vitrification process. The system has an external straw to protect the samples during storage, but the device is not hermetically sealed. Instead closed systems are devices that are hermetically sealed before vitrification and remain sealed during storage. Open systems have proven highly effective in achieving similar outcomes with vitrified oocytes compared to those achieved with fresh ones. On the contrary, closed systems have failed to be as effective as open ones when used for oocyte vitrification. Although open systems have proven to be highly efficient, where many other methods have failed, they have been related to a theoretical risk of contamination due to direct contact with liquid nitrogen. Though to date there have been no reported cases of transmission of disease after cryo-transfers either for slow freezing or vitrification, some European countries prohibit the use of open systems for vitrification. In this study, we will evaluate the results after the donor oocyte vitrification, using a modification of a current device (Cryotop®), which makes it capable of being hermetically sealed. The current study is a prospective randomized trial aimed to assess the outcome of ovum donation cycles conducted with vitrified oocytes using the closed device versus oocytes vitrified using the traditional open device.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •< 35 years old
- •Normal physical and gynecological examinations
- •No family history of hereditary or chromosomal diseases.
- •Normal karyotype
- •Negative screening for sexually transmitted diseases.
- •Oocyte recipients:
- •Oocyte recipients < 50 years old
- •Body mass index < 30
- •< 2 previous IVF failures
- •No severe male factor
- •No recurrent miscarriage
- •No hidrosalpinx
- •No adenomyosis
- •No AMH alterations
Exclusion Criteria
- •Donors and recipients not meeting inclusion criteria
Outcomes
Primary Outcomes
Survival after oocyte vitrification using the closed device Cryotop®
Time Frame: >2 hours
Survival will be evaluated morphologically two hours after warming.
Secondary Outcomes
- Embryo development(From thawing and until pregnancy outcome (0-9 months))
Investigators
Ana Cobo
Cryo-biology Unit director at IVI Valencia, Spain
Instituto Valenciano de Infertilidad, IVI VALENCIA
